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izvesti preiskavo
1 Objavljeno
okolje
Ur. l. RS, št. MP 2001-101
(a) zadevo preiskuje ali preganja država, ki ima za ta primer jurisdikcijo, razen če ta država noče ali dejansko ne more izvesti preiskave ali pregona;
(a) The case is being investigated or prosecuted by a State which has jurisdiction over it, unless the State is unwilling or unable genuinely to carry out the investigation or prosecution;
2 Objavljeno
finance
Ur. l. RS, št. MP 2003-68
(1) Če Evropski patentni urad meni, da je treba zaslišati stranke, priče ali izvedence ali opraviti pregled, izda ustrezno odločitev, v kateri opiše preiskavo, ki jo namerava izvesti, bistvena dejstva, ki jih je treba dokazati, ter dan, uro in kraj preiskave.
(1) Where the European Patent Office considers it necessary to hear the oral evidence of parties, witnesses or experts or to carry out an inspection, it shall make a decision to this end, setting out the investigation which it intends to carry out, relevant facts to be proved and the date, time and place of the investigation.
3 Končna redakcija
DRUGO
Uradniki pristojnih organov držav èlanic, ki so odgovorni za opravljanje teh preiskav, izvršujejo svoja pooblastila po izdaji pisnega dovoljenja, ki ga izda pristojni organ države èlanice, na ozemlju katere je treba izvesti preiskavo.
The officials of the competent authorities of the Member States responsible for conducting these investigations shall exercise their powers upon production of an authorisation in writing issued by the competent authority of the Member State in whose territory the investigation is to be made.
4 Končna redakcija
gospodarstvo
CELEX: 32002D0106
Odvzem vzorcev za virološke preiskave ustreljenim divjim prašičem ali živalim, ki so bile najdene mrtve, je treba izvesti skladno s točko B.1 poglavja V.
Collection of samples for virological tests from feral pigs shot or found dead must be carried out as laid down in Chapter V B.1.
5 Končna redakcija
gospodarstvo
CELEX: 32002L0060
Če so rezultati preiskav na afriško prašičjo kugo negativni, morajo države članice izvesti ukrepe, določene v členu 11(2) Direktive Sveta 92/45/EGS o problemih javnega zdravja in problemih zdravja živali povezanih z odstrelom divjadi in dajanjem mesa divjadi na trg.
Where such testing proves negative as regards African swine fever, Member States shall apply the measures laid down in Article 11(2) of Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat(11).
6 Pravna redakcija
gospodarstvo
CELEX: 31991L0068
Vsako leto je treba izvesti preiskave na reprezentativnem številu ovac in koz na vsakem gospodarstvu.
An annual test must be carried out on a representative number of the ovine and caprine animals on each bolding.
7 Pravna redakcija
DRUGO
Zato je treba izvesti najmanj 20 preiskav za najmanj en nivo koncentracije, da se zagotovi zanesljiva osnova za to določitev.
Therefore, at least 20 investigations for at least one concentration level have to be carried out in order to ensure a reliable basis for this determination.
8 Pravna redakcija
gospodarstvo
CELEX: 31991L0068
(b) izvesti epidemiološko preiskavo in črede, ki so epidemiološko povezane z okuženo čredo, morajo opraviti preiskave, določene v točki 1(b).
(b) conduct an epidemiological enquiry, and the herds linked epidemiologically to the infected herd must undergo the tests laid down in point 1 (b).
9 Pravna redakcija
promet
CELEX: 31997R2026
V takih primerih bo morala država izvoznica izvesti nadaljnjo preiskavo na podlagi dejanskih vpletenih poslov, da ugotovi, ali je bilo plačilo preseženo.
In such cases, further examination by the exporting country based on the actual transactions involved would need to be carried out to determine whether an excess payment occurred.
10 Pravna redakcija
gospodarstvo
CELEX: 32003D0422
4. Odvzem vzorcev za virološke preiskave ustreljenim divjim prašičem ali živalim, ki so bile najdene poginule, je treba izvesti skladno s poglavjem V(B)(1).
Collection of samples for virological tests from feral pigs shot or found dead must be carried out as laid down in Chapter V(B)(1).
11 Pravna redakcija
DRUGO
Vsekakor je treba izvesti vsaj eno drugačno laboratorijsko preiskavo v skladu s prejšnjim stavkom, če se prvotni histopatološki pregled izkaže za negativnega.
In any case at least one other laboratory examination should be carried out in accordance with the previous sentence if the initial histopathological examination proves negative.
12 Pravna redakcija
DRUGO
Če pristojni organ ne more izključiti možnosti TSE, morajo dati izvesti ustrezne preiskave in hraniti trup živali pod uradnim nadzorom, dokler ni znana diagnoza.
If the competent authority cannot exclude the possibility of a TSE, it should have the appropriate investigations carried out and should keep the carcasse under official supervision until a diagnosis has been made.
13 Pravna redakcija
DRUGO
Treba je predlagati analizne postopke, ki jih je moč izvesti med rutinsko preiskavo in ki imajo tako stopnjo občutljivosti, ki omogoča zanesljivo odkrivanje prekoračitev zakonsko dovoljenih najvišjih dovoljenih količin zaostankov.
Analytical procedures shall be proposed which can be carried out in the course of a routine examination and which have a level of sensitivity such as to enable violations of legally permitted maximum residue limits to be detected with certainty.
14 Pravna redakcija
DRUGO
Če so rezultati preiskav na afriško prašičjo kugo negativni, morajo države članice izvesti ukrepe, določene v členu 11(2) Direktive Sveta 92/45/EGS o problemih javnega zdravja in problemih zdravja živali povezanih z odstrelom divjadi in dajanjem mesa divjadi na trg 1.
Where such testing proves negative as regards African swine fever, Member States shall apply the measures laid down in Article 11(2) of Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat f).
15 Pravna redakcija
DRUGO
Če se uradno potrdi prisotnost ene od oblik TSE, mora pristojni organ izvesti vse potrebne ukrepe, vključno z uničenjem trupa živali, uvesti preiskavo za ugotovitev vseh živali, izpostavljenih tveganju, ter za določitev omejitev gibanja vseh takih živali in proizvodov živalskega izvora.
In the event of official confirmation of the presence of a TSE, the competent authority should take all the necessary measures, including having the carcasse destroyed, carrying out an investigation in order to identify all animals at risk and placing movement restrictions on the animals and the products of animal origin identified as such.
16 Pravna redakcija
DRUGO
Sum prisotnosti katere koli oblike TSE pri kateri koli živali je treba sporočiti pristojnemu organu, ki mora nemudoma izvesti vse ustrezne ukrepe, vključno z odreditvijo omejitve gibanja za žival, pri kateri se sumi prisotnost TSE med čakanjem na rezultate preiskave ali z njenim zakolom pod uradnim nadzorom.
The suspected presence of any TSE in any animal should be notified to the competent authority, which should immediately take all appropriate measures, including placing the suspect animal under movement restrictions while awaiting the results of the investigation or having it slaughtered under official supervision.
17 Pravna redakcija
promet
CELEX: 31997R0552
ker je Komisija ob posvetovanju z Odborom za splošne preferenciale pritožbo proučila 7. junija 1995; ker je bilo ocenjeno, da so dokazi, ki sta jih predložila tožnika, zadostni, da upravičijo začetek preiskave, in ker je Komisija z objavo z dne 16. januarja 1996 fn odločila, da bi bilo treba preiskavo izvesti;
Whereas the Commission examined the complaint of 7 June 1995 in consultation with the Generalized Preferences Committee; whereas the evidence put forward by the complainants was judged sufficient to justify the opening of an investigation, and whereas the Commission decided by a Notice of 16 January 1996 ( 6 ) that an investigation should take place;
18 Pravna redakcija
promet
CELEX: 32003R0964
(b) Preiskava je pokazala, da so sodelujoči tajski proizvajalci izvozniki, na podlagi primerljivih tipov izdelkov prodajali obravnavali izdelek po znatno nižji ceni kot industrija Skupnosti. Zaradi nesodelovanja Kitajske in zaradi velike raznovrstnosti tipov izdelkov in s tem uvoznih cen se za Kitajsko ni mogla izvesti primerjava cen za vsak posamezni tip.
(b) The investigation showed that, on the basis of comparable product types, the Thai cooperating exporting producers sold the product concerned at a significantly lower price than the Community industry's. As to China, in the absence of cooperation and due to the variety of product types and thus import prices, no price comparison on a type per type basis could be carried out.
19 Pravna redakcija
promet
CELEX: 31997R2026
Kadar ni nobenega takšnega sistema ali postopka, kadar tak sistem ali postopek ni upravičen ali kadar je bilo ugotovljeno in se domneva, da je upravičen, vendar je bilo ugotovljeno, da se ne uporablja ali da se ne uporablja učinkovito, bo država izvoznica navadno morala izvesti nadaljnjo preiskavo na podlagi dejanskih vključenih vložkov, da se določi, ali je bilo plačilo presežno.
Where there is no such system or procedure, where it is not reasonable, or where it is instituted and considered reasonable but is found not to be applied or not to be applied effectively, a further examination by the exporting country based on the actual inputs involved will normally need to be carried out in the context of determining whether an excess payment occurred.
20 Prevajalska redakcija
RS
EMEA
V primeru pozitivnega rezultata testiranja s semikvanititativnimi testnimi lističi (beljakovine > 30 mg/ dl), je treba izvesti preiskavo urina za določitev razmerja beljakovin in kreatinina in odvzeti vzorec krvi za meritev vsebnosti kreatinina, albumina in BUN.
In case of positive semiquantitative dipstick results (protein > 30 mg/dl), urinalysis should be performed to determine urinary protein creatinine (UPC) ratio, and a blood sample to measure creatinine, albumin and BUN.
21 Prevajalska redakcija
izobraževanje
CELEX: 31991L0068
Vsako leto je treba izvesti preiskave na reprezentativnem številu ovac in koz na vsakem gospodarstvu.
An annual test must be carried out on a representative number of the ovine and caprine animals on each holding.
22 Prevajalska redakcija
izobraževanje
CELEX: 32003R1702
poročati nosilcu certifikata tipa ali odobritve projekta o vseh primerih, ko je proizvodna organizacija dala v promet proizvode, dele ali naprave in je bilo pozneje ugotovljeno, da morda odstopajo od veljavnih podatkov, ter z nosilcem certifikata tipa ali odobritve projekta izvesti preiskavo, da se najdejo tista odstopanja, ki bi lahko povzročila nevarne pogoje;
Report to the holder of the type-certificate or design approval, all cases where products, parts or appliances have been released by the production organisation and subsequently identified to have possible deviations from the applicable design data, and investigate with the holder of the type-certificate or design approval in order to identify those deviations which could lead to an unsafe condition.
23 Prevajalska redakcija
izobraževanje
CELEX: 31993D0342
treba je izvesti epizootiološko preiskavo, da se odkrijejo vir okužbe in možnosti za širjenje okužbe;
an epizootiological inquiry has to be carried out to discover the source of infection and its possible spread;
24 Prevajalska redakcija
izobraževanje
CELEX: 32003R1702
poročati nosilcu certifikata tipa, certifikata tipa z omejitvami ali odobritve projekta o vseh primerih, ko je proizvajalec dal v promet proizvode, dele ali naprave in je bilo pozneje ugotovljeno, da odstopajo od veljavnih podatkov, ter z nosilcem certifikata tipa, certifikata tipa z omejitvami ali odobritve projekta izvesti preiskavo, da se ugotovijo tista odstopanja, ki bi lahko povzročila nevarne pogoje;
Report to the holder of the type-certificate, restricted type-certificate or design approval, all cases where products, parts or appliances have been released by the manufacturer and subsequently identified to have deviations from the applicable design data, and investigate with the holder of the type-certificate, restricted type-certificate or design approval to identify those deviations which could lead to an unsafe condition.
25 Prevajalska redakcija
RS
EMEA
- Pred začetkom zdravljenja z zdravilom • ORENCIA je treba izvesti preiskave na nekatere okužbe, v skladu z ustreznimi smernicami.
• See the ORENCIA package leaflet for more information. • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
26 Prevajalska redakcija
izobraževanje
CELEX: 31997L0012
opraviti je treba epidemiološko preiskavo in v čredah, ki so epidemiološko povezane z okuženo čredo, izvesti ukrepe, določene v (ii).
an epidemiological inquiry must be conducted and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in (ii).
27 Prevajalska redakcija
izobraževanje
CELEX: 31997L0012
opraviti je treba epidemiološko preiskavo in v čredah, ki so epidemiološko povezane z okuženo čredo, izvesti ukrepe, določene v (ii).
an epidemiological inquiry must be conducted, and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in (ii).
28 Prevajalska redakcija
izobraževanje
CELEX: 31991L0068
izvesti epidemiološko preiskavo in črede, ki so epidemiološko povezane z okuženo čredo, morajo opraviti preiskave, določene v točki 1(b).
conduct an epidemiological enquiry, and the herds linked epidemiologically to the infected herd must undergo the tests laid down in point 1 (b).
29 Prevajalska redakcija
izobraževanje
CELEX: 31996L0054
Če v slednji skupini obstajajo dokazi o učinkih, je treba izvesti tudi mikroskopsko preiskavo tkiv kokoši iz skupin s srednjim in nizkim odmerkom.
When there is evidence of effects in the high dose group, microscopic examination should also be carried out in hens from the intermediate and low dose groups.
30 Prevajalska redakcija
izobraževanje
CELEX: 31996L0054
Če se uporabi satelitska skupina, je treba izvesti histopatološko preiskavo na tkivih in organih, na katerih so bili v tretiranih skupinah opaženi učinki.
When a satellite group is used, histopathology should be performed on tissues and organs identified as showing effects in the treated groups.
31 Prevajalska redakcija
izobraževanje
CELEX: 32004D0804
Kadar je potrebno, mora preiskave izvesti Evropski urad za boj proti prevaram (OLAF) v skladu z Uredbo (ES) št. 1073/1999 Evropskega parlamenta in sveta [4].
Where necessary, investigations must be conducted by the European Anti-Fraud Office (OLAF) and governed by Regulation (EC) No 1073/1999 of the European Parliament and of the Council(4).
32 Prevajalska redakcija
RS
EMEA
Da je bolnico, ki je zanosila, treba napotiti k specialistu ali zdravniku z izkušnjami v o teratologiji, ki mora izvesti diagnostične preiskave in podati svoje mnenje.
oThe need to refer patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice.
33 Prevajalska redakcija
izobraževanje
CELEX: 31992L0119
V tem primeru mora pristojni organ pred potrditvijo bolezni izvesti nadaljnje preiskave, zlasti ponovno vzorčenje in ponovno testiranje z zbiranjem vzorcev v intervalu vsaj 28 dni.
In the latter case the competent authority shall, before confirming the presence of the disease, undertake further investigations, in particular resampling and retesting with an interval of 28 days at least between collections of samples.
34 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
Kadar je za pojasnitev mehanizmov delovanja primerno, je treba izvesti posebne histološke (barvanje) in histokemične postopke in preiskave z elektronskim mikroskopom ter jih v poročilu navesti.
Where relevant to the elucidation of mechanism of action and available, special histological (staining) techniques, histochemical techniques and electron microscopic examinations, must be conducted and reported.
35 Prevajalska redakcija
RS
EMEA
V kontrolnem seznamu za zdravnike morajo biti posebej poudarjene kontraindikacije za uporabo ambrisentana in pomembna dejstva/ preiskave, ki jih je treba poznati/ izvesti pred začetkom zdravljenja, vključno s/ z:
The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including:
36 Prevajalska redakcija
izobraževanje
CELEX: 31978L1026
Organi navedene države sami odločijo o naravi in obsegu preiskave, ki jo je treba izvesti, in obvestijo državo članico gostiteljico o vsakem posledičnem ukrepu v zvezi s potrdili ali dokumenti, ki so jih izdali.
The authorities in that State shall themselves decide on the nature and extent of the investigation to be made and shall inform the host Member State of any consequential action which they take with regard to the certificates or documents they have issued.
37 Prevajalska redakcija
izobraževanje
CELEX: 31997R0552
ker je bilo ocenjeno, da so dokazi, ki sta jih predložila tožnika, zadostni, da upravičijo začetek preiskave, in ker je Komisija z objavo z dne 16. januarja 1996 [6] odločila, da bi bilo treba preiskavo izvesti;
whereas the evidence put forward by the complainants was judged sufficient to justify the opening of an investigation, and whereas the Commission decided by a Notice of 16 January 1996 (6) that an investigation should take place;
38 Prevajalska redakcija
izobraževanje
CELEX: 31978L1026
Organi navedene države sami odločijo o naravi in obsegu preiskave, ki jo je treba izvesti, in obvestijo državo članico gostiteljico o vsakem posledičnem ukrepu v zvezi z informacijami, ki so jih poslale v skladu z odstavkom 1.
The authorities in that State shall themselves decide on the nature and extent of the investigation to be made and shall inform the host Member State of any consequential action which they take with regard to the information they have forwarded in accordance with paragraph 1.
39 Prevajalska redakcija
izobraževanje
CELEX: 32002R0472
Države članice in zainteresirane stranke (kakor npr. poklicna združenja) morajo izvesti preiskave in raziskave, da ugotovijo različne dejavnike, ki sodelujejo pri nastanku ohratoksina A, in določijo preventivne ukrepe, ki jih je treba sprejeti za zmanjšanje prisotnosti ohratoksina A v teh živilih.
Investigations and research should be undertaken by Member States and interested parties (such as professional organisations) to determine the different factors involved in the formation of ochratoxin A and to determine the prevention measures to be taken to reduce the presence of ochratoxin A in these foodstuffs.
40 Prevajalska redakcija
izobraževanje
CELEX: 31998R2821
ker mora Komisija preučiti prepoved najpozneje do 31. decembra 1998 na podlagi rezultatov raznih preiskav v zvezi z razvijanjem odpornosti ob uporabi antibiotikov, zlasti glukopeptidov, in programa nadzora antimikrobne odpornosti pri živalih, ki so prejemale antibiotike, kar morajo izvesti zlasti osebe, odgovorne za dajanje teh dodatkov v promet;
whereas that prohibition has to be reviewed by the Commission not later than 31 December 1998, on the basis of the results of the various investigations concerning the development of resistance by the use of antibiotics, in particular glycopeptides, and the programme of surveillance of antimicrobial resistance in animals which have received antibiotics, to be carried out in particular by the persons responsible for putting the additives concerned into circulation;
41 Prevajalska redakcija
izobraževanje
CELEX: 31993L0053
Če epizootiološka preiskava pokaže, da se je bolezen morda prenesla iz odobrene cone ali iz druge odobrene gojilnice, ali da se je morda prenesla na drugo odobreno gojilnico kot posledica gibanja rib, jajčec ali gamet, vozil ali ljudi, oziroma na kakršen koli drug način, je te cone ali gojilnice treba obravnavati, kot sumljiva, ter izvesti ustrezne ukrepe.
If the epizootic investigation reveals that the disease could have been introduced from an approved zone or from another approved farm, or could have been transferred to another approved farm as a result of the movement of fish, eggs or gametes, vehicles or persons, or in any other way, those zones or farms shall be considered suspect and the appropriate measures shall apply.
42 Prevajalska redakcija
RS
EMEA
V primeru klinično pomembnega zastajanja tekočin, ki se pojavi med zdravljenjem z ambrisentanom, s posledičnim povečanjem telesne mase ali brez, je treba izvesti dodatne preiskave za ugotovitev vzroka, tako v povezavi z ambrisentanom kot osnovnim srčnim popuščanjem, in presoditi o morebitni potrebi po specifičnem zdravljenju ali ukinitvi zdravljenja z ambrisentanom.
If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.
43 Prevajalska redakcija
izobraževanje
CELEX: 32001L0036
Za vrednotenje srednjeročnih in dolgoročnih učinkov po akutni, subakutni in polkronični izpostavljenosti mikroorganizma je treba uporabljati možnosti, predpisane v večini smernic OECD, da je treba razširiti zadevne študije z obnovitveno dobo (po kateri je treba izvesti izčrpno makroskopsko in mikroskopsko patologijo, vključno s preiskavo mikroorganizmov v tkivih in organih).
To evaluate medium- and long-term effects after acute, sub-acute or semi-chronic exposure to micro-organisms, it is necessary to use the options provided in most of the OECD guidelines, to extend the studies concerned with a recovery period (after which full macroscopic and microscopic pathology is to be performed, including an exploration for micro-organisms in the tissues and organs).
44 Prevajalska redakcija
izobraževanje
CELEX: 31996L0093
Organ zagotovi, da imajo uradno pooblaščene osebe za certificiranje zadovoljivo znanje o veterinarski zakonodaji v zvezi z živalmi ali proizvodi, ki jih je treba certificirati, in da so na splošno seznanjeni s pravili, ki jih je treba upoštevati pri pripravi in izdaji spričeval, in - po potrebi - v zvezi z vrsto in obsegom poizvedb, testiranj ali preiskav, ki jih je treba izvesti pred certificiranjem.
The authority shall ensure that certifying officers have a satisfactory knowledge of the veterinary legislation as regards the animals or products to be certified and, in general, are informed as to the rules to be followed for drawing up and issuing the certificates and - if necessary - as to the nature and extent of the enquiries, tests or examinations which should be carried out before certification.
45 Prevajalska redakcija
RS
EMEA
Kontrolni seznam za zdravnike V kontrolnem seznamu za zdravnike morajo biti posebej poudarjene kontraindikacije za uporabo ambrisentana in pomembna dejstva/ preiskave, ki jih je treba poznati/ izvesti pred začetkom zdravljenja, vključno s/ z: • preiskavami delovanja jeter. • določitvijo rodne dobe pri bolnicah. • testom za ugotavljanje nosečnosti pri bolnicah v rodni dobi. • preverjanjem, če ženska v rodni dobi uporablja zanesljivo metodo kontracepcije.
3/4 Physician checklist The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including: • Liver function tests. • Determination of child bearing potential in female patients. • Pregnancy test if female patient with childbearing potential. • That women of child bearing potential are on reliable contraception.
46 Prevajalska redakcija
RS
EMEA
Države članice se morajo o podrobnostih sistema nadzorovane distribucije dogovoriti z imetnikom dovoljenja za promet z zdravilom v skladu z nacionalnimi predpisi in sistemom zdravstvenega varstva ter zagotoviti njegovo izvajanje na nacionalnem nivoju tako, da imajo pred začetkom predpisovanja zdravila (in po presoji države članice, izdajanja zdravila) vsi zdravstveni delavci, ki bodo predpisovali (in kjer je primerno, izdajali) zdravilo Volibris na voljo naslednje: • • • podatke o zdravilu (Povzetek glavnih značilnosti zdravila (SmPC) in Navodilo za uporabo) podatke o zdravilu Volibris za zdravstvene delavce kontrolni seznam dejstev/ preiskav, ki jih morajo poznati/ izvesti zdravniki pred začetkom zdravljenja
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that prior to prescribing (and at the discretion of the Member State, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following:
47 Prevajalska redakcija
RS
EMEA
• - Izključitev nosečnosti pred začetkom zdravljenja in mesečno izvajanje testov za ugotavljanje nosečnosti med zdravljenjem. • - Ženskam (tudi ženskam z amenorejo) je treba svetovati, da morajo med zdravljenjem in še en mesec po trajni ukinitvi zdravljenja uporabljati zanesljivo metodo kontracepcije. • - Opredeliti je treba zanesljivo metodo kontracepcije in v primeru negotovosti, kaj je primerno za posamezno bolnico, pridobiti mnenje specialista. • - Ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije mora zdravnika, ki ji je predpisal kontracepcijo obvestiti, da jemlje zdravilo Volibris. • --- Ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije, mora o tem obvestiti zdravnika, ki ji je predpisal zdravilo Volibris. • - Bolnica, ki misli, da je zanosila, mora o tem nemudoma obvestiti svojega zdravnika. Če se nosečnost potrdi, je treba uvesti alternativno obliko zdravljenja. • - Bolnico, ki je zanosila, je treba napotiti k specialistu ali zdravniku z izkušnjami v teratologiji, ki mora izvesti diagnostične preiskave in podati svoje mnenje. • -- Poročati je treba o vseh primerih nosečnosti, do katerih je prišlo med zdravljenjem.
• Exclusion of pregnancy prior to treatment initiation and monthly pregnancy testing during treatment. • The need to advise women (even if a woman has amenorrhoea) on the use of reliable contraception during treatment and for one month following permanent discontinuation of treatment. • Definition of reliable contraception and the need to seek expert advice if unsure what is suitable for an individual patient. • That if a woman of child-bearing potential needs to change or stop her method of contraception she should inform the physician prescribing her contraception that she is taking Volibris. • That if a women of child-bearing potential needs to change or stop her method of contraception she should inform the physician prescribing Volibris. • That the patient should contact her doctor immediately if pregnancy is suspected and that alternative therapy should be initiated if pregnancy confirmed. • The need to refer patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice. • To report all cases of pregnancy occurring during therapy.
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